Regulatory: Page 238

Fuji mammo CR gets FDA nod
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received an approvable letter from the U.S. Food and Drug Administration for its computed radiography for mammography (FCRm) device.
May 30, 2006
Health IT bill moves forward in U.S. Congress
By AuntMinnie.com staff writers
Legislation that would promote the use of healthcare information technology passed out of a key subcommittee yesterday in the U.S. House of Representatives.
May 24, 2006
UltraSPECT gets U.S. patent
By AuntMinnie.com staff writers
Israeli nuclear medicine developer UltraSPECT has received a U.S. patent, 7,026,623, for its "efficient single-photon emission imaging," according to the Haifa-based vendor.
May 24, 2006
Varian gets FDA nod for Trilogy applications
By AuntMinnie.com staff writers
Radiation oncology vendor Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for new applications for its Trilogy family of linear accelerators, as well as a new Trilogy Tx image-guided radiosurgery model.
May 22, 2006
Boston Scientific gets EC nod for added Liberte uses
By AuntMinnie.com staff writers
Interventional device firm Boston Scientific reported that it has received indication extensions to the European CE Mark for its Taxus Liberte paclitaxel-eluting coronary stent system.
May 15, 2006
New MRI scanners, applications lead to regulatory upgrades
By Eric Barnes
PEBBLE BEACH, CA - As imaging and interventional applications have multiplied and scanners have grown more powerful in recent years, the dangers in the MRI environment have increased as well. To address the safety issues, regulatory bodies are currently updating old MRI safety standards and are developing new ones, according to a presentation at the Society for Medical Innovation and Technology (SMIT) meeting on Friday.
May 14, 2006
NOPR to host conference call
By AuntMinnie.com staff writers
The U.S. National Oncologic PET Registry (NOPR) said that it will hold an informational conference call for registry participants on Monday, May 15, from 1 p.m. to 2 p.m. EDT.
May 11, 2006
GE gets FDA nod for Voluson i
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration clearance for its Voluson i 4D compact ultrasound system.
May 10, 2006
Novadaq lands Spy revision 510(k)
By AuntMinnie.com staff writers
Novadaq Technologies of Toronto said it has received 510(k) clearance from the U.S. Food and Drug Administration for a labeling revision of its Spy intraoperative imaging system.
May 8, 2006
U.S. NRC signs off on NAS brachytherapy
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) said that the Advisory Committee on the Medical Uses of Isotopes to the U.S. Nuclear Regulatory Commission (NRC) has completed its review of its low-dose-rate breast brachytherapy treatment.
May 7, 2006
Hologic gets DEXA clearance
By AuntMinnie.com staff writers
Hologic has received U.S. Food and Drug Administration clearance to market the use of its Discovery dual-energy x-ray absorptiometry (DEXA) system for cardiovascular applications.
May 4, 2006
IDev gets CE Mark for stent
By AuntMinnie.com staff writers
Peripheral vascular disease treatment developer IDev has received the CE Mark for its nitinol stent in Europe.
May 3, 2006
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